A randomised trial of postoperative radiation therapy following wide excision of neurotropic melanoma of the head and neck

Not Applicable

Recruiting

• Conditions: eutropic Melanoma of Head and Neck; Neutropic Melanoma of Head and Neck; Cancer - Malignant melanoma

• Registration Number: ACTRN12611000212954
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Aged 18 years or older
- Has provided written informed consent for participation in this trial
- Histologically confirmed neurotropic primary melanoma
- Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary)
- Complete macroscopic resection of all known disease with negative microscopic margins
- No previous surgery for melanoma (other than complete macroscopic resection as stated above)
- No evidence of in-transit, nodal or distant metastases as determined by clinical examination, and any form of imaging
- ECOG performance status score of 2 or less
- Life expectancy greater than 6 months
- Patients capable of childbearing are using adequate contraception
- Available for follow up

Exclusion Criteria

- Women who are pregnant or lactating
- Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition
- Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour
- Inability to localise surgical bed on any form of imaging and/or surgical margins (cm) not known
- Previous radical radiation therapy to the head and neck, excluding superficial radiation therapy to cutaneous SCC or basal cell carcinoma, which is not within or overlapping the tumour bed
- High risk for poor compliance with therapy or follow-up as assessed by investigator
- Patients with prior cancers, except: those diagnosed greater than or equal to 5 years ago with no evidence of disease relapse and clinical expectation of relapse of less than 5%; prior successfully treated Level 1 cutaneous melanomas greater than or equal to 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix
- Albinism
- Participation in other clinical trials with the same primary endpoint

Study & Design

• Study Type: Interventional
• Study Design: Not specified